Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

— GIMICC  

Official title:

Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer: Initiating a Prospective Multicenter Cohort (GIMICC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941080
• Other study ID #: 201900296
• Status: Recruiting
• Start date: September 9, 2020
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: University Medical Center Groningen
• Contact: J. J. de Haan, MD, PhD
• Phone: +31 50 3612821
• Email: j.j.de.haan[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable CRC are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

Description:

Although systemic treatment for metastasized or irresectable colorectal cancer (CRC) is becoming increasingly effective, overall survival is still poor and side effects of current treatment modalities are substantial. There is an urgent need for novel therapies, and in addition, better predictive tools are needed to select the right drug to the right patient. New data suggest that modulation of the microbiome of the gut might provide opportunities to increase anti-tumor efficacy of immunotherapy. Whereas the relation between the gut microbiome and immunotherapy is intensively studied, the relation between the gut microbiome and efficacy of conventional chemotherapy is unknown. A better understanding of the composition, function and dynamics of the gut microbiome before and during chemotherapy might help to identify factors that can be influenced during the treatment of patients with metastasized or irresectable CRC. Therefore, in this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable CRC are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Patients with histologically confirmed CRC with an indication for palliative systemic anti-tumor therapy (ANY combination of chemotherapy with/without anti-VEGF of anti-EGFR therapy)
• Measurable disease according to RECIST v1.1.
• Stored pathological specimens available
• Life expectancy = 12 weeks
• Signed Informed Consent Form
• Ability to comply with protocol

Exclusion Criteria:

• Previous (neo)adjuvant chemotherapy < 6 months
• Previous radiotherapy on the small or large intestine < 1month
• Previous surgery of the small or large intestine < 1 month
• Uncontrolled inflammatory bowel disease
• Participation in a study with a potential effect on the gut microbiome

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• fecal sample
patients will collect fecal samples at home prior to treatment and at 3 months after start of treatment at the time of response evaluation using a standard stool-collection-kit.

Behavioral:
• questionnaire
At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.

Diagnostic Test:
• Blood sample
4 tubes of blood are collected prior to treatment and at 3 months after start of treatment at the time of response evaluation and sent to the UMCG for storage.

Locations

Country	Name	City	State
Netherlands	Wilhelmina Ziekenhuis	Assen
Netherlands	Ziekenhuis Nij Smellinghe	Drachten
Netherlands	Treant Zorggroep	Emmen
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Tjongerschans Ziekenhuis	Heerenveen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Ommelander Ziekenhuis Groep	Scheemda
Netherlands	Antonius Zorggroep	Sneek

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of response to conventional systemic anti-tumor therapy conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer	To determine which bacteria species in the microbiome predict response to conventional systemic anti-tumor therapy according to RECIST v1.1 for metastatic or irresectable colorectal cancer	2 years
Secondary	Prediction of serious side effects to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer	To determine which bacteria strains in the microbiome predict serious side effects (grade 3/4 according to CTCAE v4.03) to conventional systemic anti-tumor therapy for metastatic or irresectable colorectal cancer	2 years